UW Human Research Protection Program Newsletter - Fall 2015

About the Human Research Protection Program (HRPP)

The UW HRPP provides oversight for all research activities involving human participants at UW-Madison. The HRPP is not an office, but rather a collective effort of all who participate in the conduct, approval, review, and facilitation of human participants research. To ensure our research is ethically conducted and of the highest quality, the HRPP maintains policies (indexed here) that human participants research conducted on campus must comply with.

The UW's HRPP has been an AAHRPP accredited program since 2008 (with re-accredited in 2011). AAHRPP accreditation indicates that our institution follows the highest standards for ethics, quality, and human participants protections. It also allows for more opporunities of collaborative research with other institutions. We will be submitting an application for our next re-accreditation cycle later this year, and the institution will be visited by AAHRPP next fall (2016). There will be more information regarding re-accreditation in future communications from the HRPP.

The Office of Research Policy (ORP) staff support many day-to-day operations of the HRPP. If you have questions or general comments regarding the HRPP, ORP staff can be reached at HRPP@grad.wisc.edu.

Post-Approval Monitoring Program

Since its initiation this spring, the HRPP's Post-Approval Monitoring (PAM) Program has completed routine monitoring review of about 60 human research studies from all parts of campus. The post-approval monitors would like to thank investigators and study teams for the time and the attention they have dedicated this important process. Following the completion of these initial reviews, the most common findings of noncompliance include the following:

Consent noncompliance: obtaining consent with a consent form that is either unstamped, expired, or not the most currently approved version.

Protocol noncompliance: not completing study assessments as described in the protocol/IRB application (this has included both not completing assessments or completing unapproved assessments).

In addition to helping ensure research compliance across campus, the HRPP is using the results from routine reviews to develop trainings that are tailored to fill some of the knowledge gaps that are demonstrated by these common instances of noncomplince. As these trainings are developed, they will be made available to study teams in various formats (e.g. online, in-person presentations, ad hoc consultation, etc.).

Proposed Common Rule Changes

On Septemeber 8, 2015, the federal government released the Notice of Proposed Rulemaking (NPRM) for changes proposed to the Federal Policy for the Protection of Human Subjects (the Common Rule). We have created a list of resources where researcheres can learn more about the changes proposed in this NPRM. The link below also has an online form where researchers can ask questions of or provide comments to the Office of Research Policy regarding these proposed changes.

Additional Federal Agency Requirements

When conducting research with certain government entities there are additional regulatory and reporting requirements that investigators and IRBs must be aware of. A failure to comply with these requirements can lead to complications with funding. The HRPP has created helpful documents that highlight these additional requirements.

These documents, along with many other helpful resources, can be found on the HRPP Resources for Researchers page. If there are resources you feel would be helpful to other researchers on campus, you can recommend additions to this page by emailing Ryan Moze.